Overview

Canada is one of the early implementers of medical device regulations back in 1975. Their regulations were strengthened further in 1998 with the implementation of Medical Device rules, SOR/98-282 in lines with International Medical Device Regulators Forum (IMDRF). With risk-based classification in implementation, decoding them becomes crucial for deciding on whether to apply for Establishment License and Regulatory approval. Canada also has other certification before approval. With stringent regulations for post-market surveillance and special regulations for implanted devices, procuring device market approval in the country may prove challenging.

Freyr’s team of experts decode the device classification and layout the strategic roadmap for Regulatory process for in-time market approvals. Freyr also assists in preparation for compliance to Canadian Medical Device Conformity Assessment System (CMDCAS)-ISO 13485:03 and concerned document compilation.  We specialize in serving end-to-end Regulatory needs of clients pertaining to Medical Devices right from device classifications to market-entry.

Canada Market Entry for Medical Devices - Process Flow

Canada Medical Device Regulations

 

Freyr Expertise

  • Regulatory Assistance for Establishment License Procurement
  • Medical Device Classification
  • Support for CMD CAS Procurement
  • Document Compilation and Submission Support
  • Post-market Surveillance 

Summary

S. No

Requirement

Canada

1

Regulatory Authority

Health Canada

2

Regulation

Medical Devices Regulations (SOR/98-282)

3

Risk Classification

Class I

Class II

Class III

Class IV

4

Regulatory Pathway

Class I

No Need

Class II

Medical Device License

Class III

Class IV

5

Authorized Representative

No Requirement

6

Fee payable

Class I

NA

Class II

$381*

Class III

$ 5,469 - $ 9310*

Class IV

$12,720 - $21,683*

7

QMS Requirement

CMDCAS (ISO 13485)

8

Assessment of Technical Data

Health Canada

9

Validity of License

Unlimited

10

Labelling Requirements

Part 21 of MDR (SOR/98-282)

11

Submission format

Paper

12

Final Outcome

Class I

Establishment License

 

 

Class II

Medical Device License

 

 

Class III

 

 

Class IV

13

Timelines

Class I

NA

 

 

Class II

15 Days

 

 

Class III

60 Days

 

 

Class IV

75 Days

14

Language

English & French

*The price is as per records at the time of documentation and is subject to change.